Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance.

AIMS: To evaluate the number and nature of reported congenital malformations (CMs) after intrauterine exposure to non-tumour necrosis factor inhibitor biologics (non-TNFi biologics) compared to certolizumab pegol (CZP). METHODS: A retrospective comparative study was conducted in the EudraVigilance (EV) database. A safe biologic (CZP) was considered as the reference group. Odds ratios (ORs) for CMs were calculated for each non-TNFi biologic (including abatacept, anakinra, belimumab, ixekizumab, rituximab, secukinumab, tocilizumab, ustekinumab and vedolizumab), versus CZP (quantitative assessment). Then, CM patterns were reviewed in consultation with a clinical geneticist (qualitative assessment). RESULTS: ORs were not statistically significant except for belimumab and vedolizumab (similar in magnitude). Except for vedolizumab, no specific CM patterns were observed for the included non-TNFi biologics. Three cases of corpus callosum agenesis (CCA) were identified for vedolizumab (versus none in CZP and other investigated non-TNFi biologics). Two of the CCA cases were associated with other neurological CMs (one cerebral ventriculomegaly with microcephaly and one polymicrogyria). This may indicate that these CCAs are related to undiagnosed genetic alterations or are associated with the underlying maternal disease, although a definite relationship with vedolizumab exposure cannot be ruled out. CONCLUSION: No special safety signal was identified regarding the occurrence of CMs after exposure to abatacept (n = 64), anakinra (n = 20), belimumab (n = 93), ixekizumab (n = 29), rituximab (n = 57), secukinumab (n = 128), tocilizumab (n = 124) and ustekinumab (n = 215). Regarding observed CCAs in the vedolizumab group (n = 113), no firm conclusions can be made based on available information.

Injuries in Ballroom DanceSport: A Retrospective Study on Prevalence and Relation With Demographic Data.

BACKGROUND: DanceSport is a variant of Ballroom dancing, a style that is performed as a couple dancing together. Although there are many participants worldwide, the amount of research on injuries done in this style of dancing is limited. OBJECTIVE: The aim of this study was obtaining information about the DanceSport Athletes in the Netherlands including anthropometrics, level, frequency and duration of dance training per week. Our second objective was to investigate injury prevalence and type of injuries. STUDY DESIGN: Retrospective questionnaire study. METHODS: All 816 registered active dancers within the Dutch DanceSport Association received an online questionnaire with questions on anthropometrics, level of dancing, frequency and duration of dance training, and questions on injuries. The Chi-Square test was used to calculate differences between categorical variables. RESULTS: A total of 218 dancers (33.7%) completed the questionnaire, 107 males (49.1%), and 111 females (50.9%). The mean age for men was 42 ± 15.9 and 36 ± 15.1 for women. 176 dancers (80.7%) reported 1 or more injuries. Foot, ankle, and lower leg injuries were reported most frequently, 49 males (45.8%), and 60 females (54.1%). No significant difference was found in the total number of injuries for the variables sex (P = .761) and discipline (P = .225). Significantly more head and neck injuries were identified in female Standard dancers (P < .001) compared to male dancers. Also, Standard dancers have more back injuries compared to dancers in both disciplines (P < .009). CONCLUSION: With the described anthropometrics and an 80% lifetime prevalence of injuries, this group can be compared to other dance forms. Significant differences in injuries of the head and neck for female Standard dancers compared to male dancers and significantly more back injuries in Standard dancers compared to dancers in both disciplines were found. Future studies need to translate and validate existing questionnaires in Dutch for use in this population.

Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study.

PURPOSE: To assess the compliance with the isotretinoin Pregnancy Prevention Programme (PPP) by evaluating the use of prescribed contraceptives among isotretinoin users. The PPP contains a requirement for the use of contraceptive methods for women of childbearing potential. METHODS: A drug utilisation study was performed using data from a drug prescription database (containing Dutch community pharmacy data) covering a population of 500 000 patients. Contraceptive use in female isotretinoin users and in a reference group of female non-isotretinoin users (aged 15-49 years) was compared using data from 1999 until 2006 in 2-year periods. Descriptive statistics were used. RESULTS: Of the female isotretinoin users (n = 651), 52%-54% filled prescriptions on contraceptives in strict accordance to the PPP, used before, during, and after discontinuation of isotretinoin, compared with 39%-46% in the reference group. A more liberal approach of a minimum of one prescription for a contraceptive method showed 61%-64% use of contraceptives among isotretinoin users. Similar patterns were seen when data were broken down in age groups. Furthermore, a higher proportion of female patients using isotretinoin prescribed by general practitioners used prescribed contraceptives compared with those receiving isotretinoin by specialists. CONCLUSION: Compliance with the contraceptive use according to a PPP for a teratogenic drug such as isotretinoin is 52%-64%, which is lower than anticipated. Reasons for the low compliance will need to be clarified before further measures can be taken.

The distribution of congenital anomalies within the VACTERL association among tumor necrosis factor antagonist-exposed pregnancies is similar to the general population.

OBJECTIVE: To compare the distribution of congenital anomalies within the VACTERL association (vertebral defects, anal atresia, cardiac, tracheoesophageal, renal, and limb abnormalities) between patients exposed to tumor necrosis factor-α (TNF-α) antagonist and the general population. METHODS: Analysis for comparison of proportional differences to a previous publication between anomaly subgroups, according to subgroup definitions of the European Surveillance of Congenital Anomalies (EUROCAT), a population-based database. RESULTS: Most EUROCAT subgroups belonging to the VACTERL association contained only one or 2 records of TNF-α antagonist exposure, so comparison of proportions was imprecise. Only the category "limb abnormalities" showed a significantly higher proportion in the general population. CONCLUSION: The high number of congenital anomalies belonging to the VACTERL association from a report of pregnancies exposed to TNF-α antagonists could not be confirmed using a population-based congenital anomaly database.